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Safety and Pharmacodynamcis of SELA-070 Nicotine Vaccine in Smokers

NCT03148925 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2018-11-16

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and pharmacodynamics of SELA-070. Increasing subcutaneous doses of SELA-070 will be administered to healthy smoker volunteers. The resulting safety profile and anti-nicotine antibody levels will be evaluated.

Conditions

  • Smoking Cessation

Interventions

BIOLOGICAL

SELA-070

Sub-cutaneous injection, multiple dose

BIOLOGICAL

Saline

Sub-cutaneous injection, multiple dose

Sponsors & Collaborators

  • Selecta Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Alexander Lucardie, MD · SGS LSS Clinical Pharmacology Unit - Antwerpen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-11
Primary Completion
2018-10-18
Completion
2018-10-18
FDA Drug
Yes

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03148925 on ClinicalTrials.gov